Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the efficacy and safety of ckd-348(ckd-828, d326, d337) tablet

Conditions: Hypertension; Dyslipidemias

Summary: to evaluate the efficacy and safety of ckd-828, d326, and d337 combination therapy in hypertensive patients with dyslipidemia

the purpose of this phase iii study was to evaluate the efficacy and safety of ckd-348(ckd-828, d326, d337) tablet administration for treatment period(8 weeks) in essential hypertesive patients with dyslipidemia.

Eligibility criteria:
inclusion criteria: 1. between 19 years and 75 years old(male or female) 2. diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs 3. the patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to principle investigator's opinion 4. agreement with written informed consent exclusion criteria: 1. patients whose blood pressure measured at screening is one of the following: * mean sitting systolic blood pressure ≥ 200 mmhg or mean sitting diastolic blood pressure ≥ 120 mmhg * difference in mean sitting systolic blood pressure between patient's both arms ≥ 20 mmhg and mean sitting diastolic blood pressure ≥ 10 mmhg 2. patients whose lipid level measured at screening is one of the following: * low density lipoprotein-c \> 250 mg/dl or triglyceride ≥ 500 mg/dl 3. patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
role of transcrainal direct current brain stimulation in acute and chronic post-mastectomy pain management

Conditions: Postoperative Pain

Summary: the role of transcranial magnetic stimulation over the primary motor cortex area on acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

new analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. several novel brain stimulation technologies including transcranial direct current stimulation (tdcs) are beginning to demonstrate promise as treatments for a variety of pain conditions. electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions.transcranial direct current stimulation has been studied in patients with various disorders and multiple pain syndromes. there is also evidence that tdcs might be useful in postsurgical pain reduction.

Eligibility criteria:
inclusion criteria: * asa i-ii, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer exclusion criteria: * patients with intracranial metallic devices or with pacemakers or any other device. * patients with neurological or psychiatric disorders, * patients taking major centrally acting drugs (antiepileptics or antidepressants), -opioid dependence, * substance abuse, * severe cardiopulmonary, renal, hepatic diseases, and * those with extensive myocardial ischemia or unstable angina.

Keywords: brain stimulation, tdcs, acute postoperative pain, chronic pain
application of ai in polypectomy

Conditions: Colonic Polyp

Summary: the aim of this study was to assess the performance of ai system in polypectomy


Eligibility criteria:
inclusion criteria: * to undergo colorectal polypectomy; * agree to give written informed consent exclusion criteria: * patients with the contraindications to colorectal polypectomy; * patients with a history of inflammatory bowel disease (ibd), crc, colorectal surgery; * patients with high suspicion of polyposis syndromes, ibd and typical advanced crc; * patients refused to participate in the trial; * the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool; * the procedure have to be terminated due to complications of anaesthesia.
response based treatment for children with unresectable localized soft tissue sarcoma

Conditions: Unresectable Localized Soft Tissue Sarcoma

Summary: to evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment

response after initial chemotherapy is one of the important prognostic factor in many cancers. in this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (fdg) uptake in positron emission tomography (pet) scan.

Eligibility criteria:
inclusion criteria: * patients with unresectable localized high grade soft tissue sarcoma exclusion criteria: * patients with organ dysfunction (ejection fraction, liver function test, creatinine \> ctcae grade 2)
a study evaluating the long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in cystic fibrosis (cf) particpants 6 years and older and f/mf genotypes

Conditions: Cystic Fibrosis

Summary: the study evaluates the long-term safety and efficacy of elexacaftor (elx)/tezacaftor (tez)/ivacaftor (iva) triple combination (tc) in participants with cf who are 6 years of age and older with f/mf genotypes.


Eligibility criteria:
key inclusion criteria: * completed study drug treatment in parent study (vx19-445-116, nct04353817), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study key exclusion criteria: * history of study drug intolerance in the parent study other protocol defined inclusion/exclusion criteria may apply
novel screening strategies for scleroderma pah

Conditions: Pulmonary Arterial Hypertension; Scleroderma

Summary: patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). it is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. however, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. this study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. the study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * 30 years or older; * diagnosis of limited or diffuse scleroderma (american college of rheumatology criteria) * for the "high risk" group, one of the following features: * resting transthoracic echocardiogram showing elevated right-sided pressures within previous 3 months \[tricuspid regurgitation (tr) jet \>2.8 m/s or evidence of right ventricular dysfunction\] * pulmonary function testing (pft) showing abnormal diffusing capacity of carbon monoxide (dlco) not due to significant interstitial lung disease (dlco\ 1.4) exclusion criteria: * pregnancy * prior diagnosis of pulmonary hypertension * treatment with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogues * previous diagnosis of obstructive lung disease or pulmonary thromboembolic disease * current smoker * significant valvular disease * resting echocardiogram showing left ventricular ejection fraction\<50% within previous 3 months * resting echocardiogram showing significant (greater than grade i) diastolic dysfunction * pulmonary emboli (past or present).
the "pc-light" study

Conditions: Prostate Cancer; Sleep; Depression; Fatigue; Quality of Life

Summary: fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with quality of life and can linger long after treatment has ended, yet research examining preventative approaches has produced limited clinical benefit. the proposed study will provide information about systematic light exposure for the prevention of fatigue in prostate cancer patients undergoing radiation therapy and will investigate how it works. this study would facilitate the development of this potential preventative treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related fatigue.


Eligibility criteria:
inclusion criteria: * have been diagnosed with clinical localized prostate cancer, * are about to begin external beam radiation therapy (rt) for prostate cancer, * are 18 years of age or older, * are able to speak or read english, * have internet access. exclusion criteria: * history of light therapy use (e.g. systematic light exposure), * active infection * history of chronic fatigue disorders * confounding underlying medical illnesses such as significant pre-existing anemia (hb\<10 gm/dl) * diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment) * hypothyroidism or documented history of hypothyroidism on thyroid replacement hormone within \<3 months of initiating rt * history of bipolar disorder or mania * history of seasonal affective disorder * diagnosed sleep apnea, restless legs, or other sleep disorders (not including insomnia) known to affect fatigue * use of photosensitizing medication * plans to travel across more than 2 time zones during the study * shift worker * adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners will be excluded from the study
the use of cyclokapron for treatment and management of women with bleeding disorders

Conditions: vonWillebrand Disease; Hemophilia; Platelet Coagulation Disorders

Summary: the high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. this has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. we anticipate that tranexamic acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.

women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. if the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.

Eligibility criteria:
inclusion criteria: * all menstruating women regardless of age * women with heavy periods as measured by pictorial blood assessment chart * women diagnosed with a bleeding disorder exclusion criteria: * acquired defective color vision * factor viii, factor ix, factorxi levels \>250% * an inherited thrombophilic defect detected because of a positive family or personal history of thrombosis * current use of oral contraceptives
a study to evaluate the efficacy, safety, and drug levels of oral ozanimod in pediatric participants with moderately to severely active crohn's disease with an inadequate response to conventional therapy

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active crohn's disease.


Eligibility criteria:
inclusion criteria: * participants must have a pediatric crohn's disease activity index (pcdai) score ≥ 30 and a simple endoscopic score for crohn's disease (ses-cd) score ≥ 6 (or ses-cd ≥ 4 in participants with isolated ileal disease) * participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for crohn's disease (cd): i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for cd exclusion criteria: * participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study * participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy * participant has extensive small bowel resection (\> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition other protocol-defined inclusion/exclusion criteria apply.
sedation vs. intubation for endovascular stroke treatment

Conditions: Acute Ischemic Stroke

Summary: sedation vs intubation for endovascular stroke treatment trial (siesta) is a prospective, randomised controlled, monocentric, two-armed, comparative trial. patients are randomized 1 : 1 to either non-intubated state or to intubated state for endovascular stroke treatment. otherwise, no principal differences in intensive care treatment are intended, and standard operating procedures are applied to ensure uniform management decisions in fields such as ventilation, sedation, cardio-vascular and cerebral monitoring and management.

early recanalization is an important, if not the most important, factor concerning reconstitution of patients´ health in ischaemic stroke. this is the reason why patients with extended stroke are increasingly subjected to an endovascular stroke therapy (est). matter of ongoing debate is how to sedate these patients during intervention. some clinicians prefer an intubation due to a reduction of patients´movements and therefore potentially lowering complication rates (injury by catheter, aspiration e.g.). on the other hand retrospective investigations hypothesize that general anaesthesia is associated with peri-interventional hypotension followed by poorer clinical outcome. the best anaesthaesiologic management in endovascular stroke therapy to this point of time is not known. the investigators therefore designed this study comparing intubated state with general anaesthesia vs. non-intubated state with conscious sedation during est, focusing on patients´ outcome.

Eligibility criteria:
inclusion criteria: * age ≥18 years * acute stroke in anterior circulation * occlusion of carotid artery and/ or middle cerebral artery * planned mechanical recanalisation * informed consent from patient or legal representative exclusion criteria: * age \< 18 years * informed consent not obtainable * coma * agitation * vomiting * difficult airway management * additional cerebral hemorrhage

Keywords: ischemic stroke recanalisation sedation
amount of root resorption of maxillary anteriors after en masse versus two step space closure

Conditions: Root Resorption

Summary: the goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. th main aim of this study is to conclude which method is less damaging to the roots. participants will be divided into two groups: 1. en masse retraction (experimental) 2. two step retraction (control) pre retraction and post retraction cbct scans will be compared for both groups.


Eligibility criteria:
inclusion criteria: * patients who signed the informed consent to be part of this study. * patients with class i or class ii malocclusion. * patients requiring extractions of maxillary first premolars with absolute anchorage. * good periodontal status. exclusion criteria: * patients who are syndromic or have cleft lip and/or palate. * patients with severe root dilacerations or root canal treated incisors. * patients receiving drugs that alter tooth movement. * patients with systemic disease like endocrinological disorders, vit d excess or deficiency, thyroid or parathyroid problems. * patients with history of trauma to dentition or impacted teeth in anterior maxilla. * patients who have undergone previous orthodontic treatment.

Keywords: two step retraction en masse retraction cone beam computed tomography
a study of ixekizumab (ly2439821) in bdmard-naive participants with radiographic axial spondyloarthritis

Conditions: Spondyloarthritis

Summary: the main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bdmards)-naive participants with radiographic axial spondyloarthritis (rad-axspa).


Eligibility criteria:
inclusion criteria: * are ambulatory. * diagnosis of radiographic axial spondyloarthritis (rad-xspa) with sacroiliitis defined radiographically according to the modified new york criteria. * participants have a history of back pain ≥3 months with age at onset \<45 years. * in the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate nsaids. * if taking nsaids be on a stable dose for at least 2 weeks prior to randomization. * have a history of prior therapy for axspa for at least 12 weeks prior to screening. exclusion criteria: * have total ankylosis of the spine. * have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents. * have recently received a live vaccine within 12 weeks or have had a vaccination with bacillus calmette-guerin (bcg) within the past year. * have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis. * have a compromised immune system. * have any other serious and/or uncontrolled diseases. * have either a current diagnosis or a recent history of malignant disease. * have had major surgery within 8 weeks of baseline, or will require surgery during the study. * are pregnant or breastfeeding.

Keywords: ankylosing spondylitis
the status of helicobacter pylori infection among children visiting assiut children hospital

Conditions: Helicobacter Pylori Infection

Summary: the aim of this study is to estimate the prevalence of helicobacter pylori infection among egyptian children attending to healthcare facilitates using different diagnostic tools.

the prevalence of h. pylori infection, which has a ubiquitous distribution, varies depending on socioeco- nomic factors and age. in the context of a decreased trend in h. pylori prevalence, at least 50% of the world's hu-man population are carriers of the microorganism, with a prevalence much higher in developing countries than in developed countries. h. pylori infection was evaluated in 286 egyptian school children, and the overall prevalence was \> 72%. acquisition of the infection occurs mostly in early childhood; therefore, a better understanding of the epidemiology and the risk factors associated with h. pylori infection in the pediatric population is important to clarify the natural history and complications of the infection and programming eradication strategies. currently, little data exist regarding the epidemiology of h. pylori associated infection in our region., especially in children. therefore, this study aims to determine the prevalence of h. pylori among children.

Eligibility criteria:
inclusion criteria: * all children (\<18 years) attending healthcare facilities for any reason will be enrolled after informed consent of their parents to participate in the study. participants will be recruited from the following sources: 1. children with non-gi symptoms (ophthalmology, ear, nose, and throat , chest departments .. etc) 2. children with gi symptoms undergoing upper gi endoscopy (from gi endoscopy units). simple questionnaire will be used to collect demographic data, socioeconomic status, dietary habits, and gastrointestinal complaints from parents of all participants before testing for helicobacter pylori. exclusion criteria: 1. patients refusing to be enrolled in the study. 2. for any diagnostic test other than serology (stool antigen, rapid urease test, urea breath test, histopathology) the following patients will be excluded: * children received any antibiotics in the last month * children received bismuth compounds in the last month. * children received proton pump inhibitors in the last 2 weeks. * children presenting with upper gastrointestinal bleeding.
energy turnover and appetite

Conditions: Obesity

Summary: the aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate energy turnover.

a total of 18 adolescents with obesity, aged 12-16 years olds will complete three experimental sessions in a randomized order: i) low energy turnover; ii) moderate energy turnover and ; iii) high energy turnover. their ad libitum energy intake at dinner will be assessed through an ad libitum buffet-type meal, their food reward assessed right before the dinner meal and their appetite sensation at regular intervals during the day.

Eligibility criteria:
inclusion criteria: * bmi percentile \> 97th percentile according to the french curves. * ages 12-16 years old * signed consent form * being registered in the national social security system * no contraindication to physical activity exclusion criteria: previous surgical interventions that is considered as non-compatible with the study. * diabetes * weight loss during the last 6 months * cardiovascular disease or risks
predictors of de novo urge urinary incontinence after photoselective vaporization of the prostate

Conditions: Prostatic Hyperplasia; Urgency; Urinary Incontinence

Summary: the aim of this study was to investigate the incidence of de novo urge urinary incontinence after the photoselective vaporization of the prostate for benign prostatic hyperplasia using the validated overactive bladder symptom score, and to determine the predictors of de novo urge urinary incontinence following the photoselective vaporization of the prostate.


Eligibility criteria:
inclusion criteria: * men in whom 6-months follow-up data were available * men who did not complain of urge urinary incontinence based on the oabss (overactive symptom score): oabss question 4 score of ≤ 1 exclusion criteria: * previous prostate or bladder surgery * a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or neurogenic bladder disease
effect of isoflavone supplementation associated with physical exercise in the health parameters of postmenopausal women

Conditions: Bloodpressure

Summary: this study evaluate if 10 weeks of mixed exercise combined with isoflavones could have greater effects on climacteric symptoms, body composition and hydratation, lipidic and inflamatory profile than exercise alone in postmenopausal women. the participants will be randomly assigned to the group: placebo and exercise or 100mg of isoflavone and exercise.

several endocrine metabolic changes occur during the climacteric period, due to the lack of estrogen and also by the aging process and some studies show that ingestion of isoflavones by postmenopausal women may have benefits. theoretically the isoflavone potentiate the effects obtained during exercise

Eligibility criteria:
inclusion criteria: * healthy postmenopausal woman * to be able to practice exercises on treadmill and weight exercises * without physical complications that prevent the execution of physical exercises * have no history of cardiovascular disease, diabetes, renal pathologies or hypertension exclusion criteria: * smokers * use hormone therapy or isoflavone * use drugs that interfere with lipid and antihypertensive metabolism

Keywords: isoflavone blood pressure climateric symptoms exercise